MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY? MRI; Implantable lead

Model Number	7732
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high out of range pace impedance measurements above 3000 ohms.Technical services (ts) was consulted and upon review the impedance trend show a gradual rise.The physician opted to perform programming enhancements.No adverse patient effects were reported.This lead remains in service.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: INGEVITY? MRI
• Common Device Name: Implantable lead
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; road 698, lot no. 12; dorado PR 00646 -260; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25721848
• Report Number: 2124215-2026-35995
• Device Sequence Number: 9358245
• Product Code: NVN
• UDI-Device Identifier: 00802526523335
• UDI-Public: (01)00802526523335(17)210917
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/17/2021
• Device Model Number: 7732
• Device Catalogue Number: 7732
• Device Lot Number: 1012168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Supplement Date Received by Manufacturer: 07/20/2026; 08/11/2026; Not provided; 09/14/2026
• Initial Report FDA Received Date: 07/06/2026
• Supplement Report FDA Received Date: 08/03/2026; 08/11/2026; 08/24/2026; 09/15/2026
• Date Device Manufactured: 09/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female